SOURCES SOUGHT
B -- Sources Sought for a Study to Investigate the Sensitivity of Pharmacokinetics in Detecting Differences Physicochemical Properties
- Notice Date
- 4/19/2013
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1116092
- Archive Date
- 5/14/2013
- Point of Contact
- Tomeka Evans, Phone: 3018277168, Gina Jackson, Phone: 301-827-7181
- E-Mail Address
-
Tomeka.Evans@fda.hhs.gov, gina.jackson@fda.hhs.gov
(Tomeka.Evans@fda.hhs.gov, gina.jackson@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to investigate the sensitivity of pharmacokinetics in detecting differences in physicochemical properties of the active in suspension nasal products for local action. The Contractor's capability statement shall demonstrate the company's ability to meet the following requirements. Please provide a detailed description of your company's (including its teammates, if applicable) experience and demonstrated abilities to deliver the following: 3.1. Background At this time, for nasal suspension products intended for local action, the agency recommends that the bioequivalence (BE) be established based on a battery of in-vitro tests to establish equivalent drug delivery to nasal sites of action, pharmacokinetic (PK) studies to establish equivalent systemic exposure, and clinical endpoint studies to establish equivalent efficacy; whereas BE for nasal solution products for local action relies on establishing equivalence in in-vitro tests only. These additional in-vivo study requirements for nasal suspension products stems from the assumption that drug delivery to nasal site of action is dependent on several factors including, but not limited, drug particle size distribution (PSD). Unfortunately, at this time, there is no method that can adequately characterize drug PSD in nasal suspension products. Therefore, to establish equivalent efficacy of nasal suspension products, the agency has to rely on clinical endpoint studies, which are inherently highly variable and insensitive to dose differences. Drug PSD has the potential to influence both the rate as well as extent of drug availability to nasal sites of action and hence systemic circulation; assuming bioavailability through the gut is very low to negligible (Daley-Yates and Baker, 2001). Therefore, if systemic levels of the drug can be shown to be directly related to drug PSD; systemic PK studies could potentially be used to replace the clinical endpoint study as a surrogate indicator for equivalent drug delivery for nasal suspension products. 3.2. Objectives The project will investigate the effect of physicochemical properties of the drug in suspension nasal drug product for local action including, but not limited to, particle size, morphic form and solvation state on the pharmacokinetic behavior of the drug product. 3.3. Detailed Description Nasal suspension spray(s), containing poorly soluble drug intended for local acting in the nose, e.g., fluticasone furoate or mometasone furoate, will be developed and manufactured for this research, under cGMP. This study will comprise of two phases: 1. Nasal suspension products will be formulated using different batches of the active with different PSDs, morphic form and solvation states, and characterized for their in-vitro performance (e.g., spray pattern, plume geometry) as recommended in the Nasal BA BE guidance. 2. A comparative in-vivo PK study will be conducted using a crossover study design to assess the differences in the plasma concentration vs. time profile of the selected nasal suspension products. Duration of Project This is a 2-year project. Due to the sequential nature of the in-vitro and pharmacokinetic studies, this project is non-severable. Responses to this notice shall be limited to 5 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541712 (size standard $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the System for Award Management (SAM) to be considered as potential sources. 5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received via email to Contract Specialist Tomeka Evans at email address Tomeka.Evans@fda.hhs.gov no later than 1:00 PM Eastern Standard time on Monday 29, 2013 for consideration. Responses to this announcement will not be returned, nor any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and the FDA may contact one or more respondents for clarifications and to enhance the Governments understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1116092/listing.html)
- Place of Performance
- Address: The Place of Performance will be at the Contractor's Facility, United States
- Record
- SN03040922-W 20130421/130419234148-860b5e03b38951132faff2d674640e53 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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